Status:
COMPLETED
Nitrite Infusion Studies
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Eligibility:
All Genders
21-40 years
Phase:
PHASE1
Brief Summary
This study will examine 1) how nitrite (a natural blood substance that relaxes blood vessels) increases blood flow and lowers blood pressure, and 2) how to increase the effects of nitrite on blood pre...
Detailed Description
Although regional synthesis of nitric oxide (NO) by the endothelium contributes importantly to local vasodilator tone, we have previously shown that NO bioactivity may be transported in blood, and hav...
Eligibility Criteria
Inclusion
- ELIGIBILITY:
- A total of 30 healthy volunteers will be enrolled in this study, 20 for Part A and 10 for Part B. All volunteer subjects will undergo screening with complete history, cardiovascular physical examination, blood collection for clinical chemistry routine analyses, plus testing for G-6-P-DH deficiency in erythrocytes and blood gas analysis via cooximetry, and a pregnancy test.
- INCLUSION CRITERIA:
- Subjects must be 21-40 years of age.
- Subject must be in good health.
- Subjects must provide informed, written consent for participation in this study.
- Female subjects of childbearing age must have a negative pregnancy test.
- EXCLUSION CRITERIA:
- Subjects with a history or evidence of present or past hypertension (blood pressure greater than 140/90 mmHg), hypercholesterolemia (LDL cholesterol greater than 160 mg/dL), or diabetes mellitus (fasting blood glucose greater than 126 mg/dL)
- Subjects who have a history of smoking within two years
- Subjects who have a history of cardiovascular disease, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
- Individuals with a future cardiovascular risk greater than 1 % in the next 10 years will be excluded from the study. Risk will be calculated using the Framingham risk calculator published on the web site: http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof.
- Subjects with red blood cell G6PD deficiency (levels below the lower limits of normal).
- Subjects with known cytochrome B5 deficiency will not participate in this study.
- Subjects with a history of reaction to a medication or other substance characterized by dyspnea and cyanosis will not participate in this study.
- Subjects with a baseline methemoglobin level greater than 1.9% will not receive nitrite infusions.
- Lactating females will not participate since nitrite crosses into breast milk and could cause methemoglobinemia in the infant.
- No volunteer subject will be allowed to take any medication (oral contraceptive agents are allowed), vitamin supplements that contain arginine, herbal preparations, nutriceuticals or other "alternative therapies" for at least one month prior to study and will not be allowed to take aspirin for one week prior to study
- Subjects with a blood pressure of less than 90/60 mmHg or a MAP (mean arterial blood pressure) of less than 70 on the study day will be excluded from the protocol.
- Due to exposure of high doses of ascorbic acid in this protocol calcium oxalate stone formers, patients on dialysis or with serious kidney disease, and patients with hemochromatosis and other iron overload diseases will be excluded.
Exclusion
Key Trial Info
Start Date :
January 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00102271
Start Date
January 19 2005
End Date
April 12 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892